Cartridge packaging

Abstract

The present disclosure relates to a cartridge packaging (1) with an outer shell (3) closed in a tamper proof manner and comprising at least one cartridge (2) filled with a liquid drug for use in a pen type drug delivery device. The shell (3) is a flow wrapped film made of a flexible low-density polyethylene (LDPE) material tube which is heat sealed at two opposite ends. Optionally, a secondary packaging box (8) may be provided housing several shells (3) with cartridges (2).

Description

[0001] Description

[0002] CARTRIDGE PACKAGING

[0003] The present disclosure is generally directed to improvements in the sustainability of a packaging suitable for storing one or more spare cartridges filled with a liquid drug, e.g. for use in a pen type drug delivery device.

[0004] Pen type drug delivery devices have application where regular injection by persons without formal medical training occurs. This is increasingly common among patients having e.g. diabetes where self-treatment enables such patients to conduct effective management of their disease. In certain types of drug delivery devices, such as pen type devices, cartridges filled with a liquid drug are used. These cartridges are housed in a cartridge holder or cartridge housing. To dispense a dose of drug from such a cartridge, the drug delivery device has a dose setting and drive mechanism that uses a piston rod or lead screw moving in a distal direction and pressing the bung distally which expels a certain set dose of drug from the cartridge. Some of these devices are intended to be reused when the cartridge is empty by replacing the empty cartridge by a new cartridge, e.g. as disclosed in WO 2014 / 033195 A1. For such a cartridge replacement, spare cartridges are provided which have to be stored in a packaging reducing the risk of contamination of the cartridge and providing sufficient protection to avoid breaking of the cartridges which are often made of glass. For example, insulin cartridges are typically provided in thermoformed blister packs with an aluminium lid foil for each item.

[0005] It is an object of the present disclosure to provide an improved cartridge packaging that stores and protects at least one cartridge.

[0006] This object is solved with a cartridge packaging according to claim 1.

[0007] A cartridge packaging according to the present disclosure is substantially a set of a shell and one or more cartridges filled with a liquid drug, e.g. for use in a drug delivery device.

[0008] 16. Dezember 2025 S 100 P 559 WO The cartridge packaging has an outer shell closed in a tamper proof manner which is configured to store or house at least one cartridge filled with a liquid drug. A shell closed in a tamper proof manner means that opening the shell requires that an element, typically a seal or tear-off member, is broken and / or removed, thereby permitting a user to easily detect if the packaging was opened. Preferably, the shell is a flow wrapped film made of a flexible low-density polyethylene (LDPE) material tube which is heat sealed at two opposite ends. In other words, the cartridge is stored in and encased by a film tube sealed at both ends to form a closed packaging.

[0009] The use of flow wrap packaging technology for cartridges allows abstaining from thermoformed blister packs for each item. The elimination of the blister pack makes the cartridge packaging significantly more sustainable than the existing insulin cartridge solutions. The cartridge packaging enables more sustainable materials and processes, for example flow wrap manufactured from flexible LDPE, and cardboard. The packaging according to the present disclosure provides a number of sustainability benefits. For example, eliminating thermoformed blister packs with aluminium lid foil reduces the energy use and carbon generation associated with their production and disposal as part of the packaging. Further, the proposed cartridge packaging is more compact than the existing designs, which can increase the packaging density and efficiency of the refrigerated supply chain by reducing energy use and carbon generation for a given quantity of cartridges. In addition, flow wrapping uses significantly less polymer material than blister packs, reducing material usage and pack weight, again reducing energy consumption and carbon generation. Still further, recycling solutions are beginning to be established for LDPE flexible materials but are not available for blister packs with aluminium lid foil.

[0010] The flow wrapping cartridge packaging offers a high level of functionality in terms of individual tamper evidence, maintenance of individual cartridge sterility, protection from leakage if cartridges are broken in transit and ability to print information on the pack surface, e.g. printed onto the LDPE film.

[0011] The shell of the cartridge packaging may comprise at least one initiation notch or the like initiation features by which the individual flow wrapped cartridges can be opened. Such

[0012] 16. Dezember 2025 S 100 P 559 WO initiation features create a localised stress concentration in the material, enabling an easier tearing action.

[0013] The cartridge packaging according to the present disclosure may comprise at least two, e.g. three, cartridges which are each individually encased in a compartment of the flow wrapped film shell. If adjacent compartments are hinged to each other by one or more weakened lines, the cartridge packaging may be seen as a set of individually encased cartridges hinged to each other in a separatable manner. For example, the cartridges may be arranged substantially coaxially as a linear pack with the weakened lines extending substantially perpendicular to the longitudinal axes of the cartridges. As an alternative to such a top-to-bottom arrangement, the cartridges may be stored in a side-by-side arrangement which provides a potentially more convenient and robust pack size for user transport and storage. In other words, the cartridges may be arranged substantially parallel to each other as a side-by-side pack with the weakened lines extending substantially parallel to the longitudinal axes of the cartridges. Weakened lines may be perforated, notched or incised lines or lines with reduced material thickness.

[0014] This cartridge packaging may feature a standard hanger feature with an oblong opening that may be used in a health care setting to store and / or display the cartridges in a refrigerator.

[0015] A minimal solution of the cartridge packaging according to the present disclosure does not require additional packaging components like cardboard supports. Instructions can be provided separately as paper or digitally via a printed code.

[0016] According to a further aspect of the present disclosure, the cartridge packaging may further comprise a secondary packaging box wherein the shell is at least partially encased by the secondary packaging box. This secondary packaging box may serve to keep several individually encased cartridges together if the respective shells are not hinged to each other, i.e. it allows individual cartridge packs to be contained, i.e. they do not need to be attached to each another. The secondary packaging box may be made of a cardboard material, e.g. cardboard or corrugated cardboard.

[0017] 16. Dezember 2025 S 100 P 559 WO Such a secondary packaging box serves as a housing having several functions. For example, if it is open at the front and / or sides it permits visibility of the items. Further, it provides a more regular outer shape, allowing the packs to be handled and stored in a more efficient fashion. In addition, it provides a greater degree of protection for the flow wrapped cartridge packs. Still further, a patient instruction leaflet can be stored between the cartridge packs and the housing. A secondary packaging box also provides additional surface area for brand and / or produce information. It may also be used to provide a printed QR code for electronic patient instructions.

[0018] For example, the secondary packaging box may be made from a single piece blank comprising at least a top wall, a bottom wall, a back wall and a front wall. In addition or as an alternative, the front wall may comprise at least one withdrawal cut-out and / or the front wall may be partially folded onto the back wall. Alternatively, the secondary packaging box may further comprise a closing flap and at least one tear-off strip hinged to at least the closing flap by one or more weakened lines.

[0019] According to a still further alternative, the secondary packaging box may further comprise two opposite side walls and at least one separator wall wherein the separator wall divides the interior space of the secondary packaging box in a cartridge storing space and a user pack space. For example, the cartridge storing space may comprise several sets each comprising at least two cartridges which are each individually encased in a compartment of the flow wrapped film shell wherein adjacent compartments are hinged to each other by one or more weakened lines. Further, the user pack space may comprise several prebuilt user packs in a flat folded condition from which the user packs may be erected into a use condition. This example provides a highly efficient and flexible distribution system, enabling pharmacists to dispense an individual, i.e. variable, number of cartridge packs, as required by each patients’ individual prescription. The user packs are supplied in a flat condition to minimise the storage volume. They are then erected e.g. by the pharmacist when required. The internal separators that divide the cartridge packs, user packs and patient instructions within the box help with the management of items during packing, transit, and during the use at the pharmacy, particularly when partially full. Alternatively, instead of internal dividers, the pharmacy pack could contain smaller sub-packs of cartridges, user packs and instruction, to help manage storage in the health care setting.

[0020] 16. Dezember 2025 S 100 P 559 WO These examples reduce the volume of packaging sent through a supply chain, through the efficient storage of cartridge packs, and the flat packing of the user packs and instructions. It reduces the number of stock keeping units (SKUs) that need to be produced, stored and distributed. This concept improves manufacturing, storage and transportation efficiency and increased packing density in cold-chain, reducing energy use and carbon generation.

[0021] The cartridge packaging according to the present disclosure may comprise at least one cartridge made from a polymer-based material or from glass.

[0022] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0023] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0024] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For

[0025] 16. Dezember 2025 S 100 P 559 WO example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0026] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0027] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example

[0028] 16. Dezember 2025 S 100 P 559 WO that of human insulin, by deleting and / or exchanging at least one amino acid residue occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codea- ble, have been added to the naturally occurring peptide.

[0029] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0030] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-pal- mitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)- des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl- des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glu- tamyl)-des(B30) human insulin; B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0031] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Vic- toza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rEx- endin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C

[0032] 16. Dezember 2025 S 100 P 559 WO (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1 , ZYD-1 , GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon- Xten.

[0033] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0034] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Sax- agliptin, Berberine.

[0035] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Fol litropi n, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0036] Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above- mentioned polysaccharides, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0037] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an anti- gen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on

[0038] 16. Dezember 2025 S 100 P 559 WO tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region anti- body-like binding protein having cross-over binding region orientation (CODV).

[0039] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigenbinding antibody fragments are known in the art.

[0040] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0041] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0042] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0043] 16. Dezember 2025 S 100 P 559 WO Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0044] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608- 1 :2014(E), needle-based injection systems may be broadly distinguished into multidose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0045] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0046] In the following, non-limiting, examples of a cartridge packaging are described in more detail by making reference to the drawings, in which:

[0047] 16. Dezember 2025 S 100 P 559 WO Figure 1 shows a perspective view of a cartridge packaging according to a first example of the present disclosure;

[0048] Figure 2 shows a perspective view of a cartridge packaging according to a second example of the present disclosure;

[0049] Figure 2A shows a detail of Figure 2;

[0050] Figure 3 shows a perspective view of a cartridge packaging according to a third example of the present disclosure;

[0051] Figure 3A shows a detail of Figure 3;

[0052] Figures 4 shows a perspective view of a cartridge packaging according to a fourth example of the present disclosure;

[0053] Figure 5 shows a top view of the cartridge packaging of Figure 4;

[0054] Figure 6 shows a side view of the cartridge packaging of Figure 4;

[0055] Figures 7 shows a perspective view of a closed cartridge packaging according to a fifth example of the present disclosure;

[0056] Figure 8 shows the cartridge packaging of Figure 7 after being opened;

[0057] Figure 9 shows a perspective view of a cartridge packaging according to a sixth example of the present disclosure; and

[0058] Figure 10 shows the erection of a user pack.

[0059] The Figures show different examples of a cartridge packaging 1 according to the present disclosure, which generally consist of at least one cartridge 2 and at least one shell 3

[0060] 16. Dezember 2025 S 100 P 559 WO enclosing the cartridge 2. The same reference numerals are used for identical or similar component parts or features in all examples.

[0061] In the depicted alternative examples the packaging is provided as a flow wrapped cartridge. In the most simple form, a single cartridge 2 is flow wrapped in a tubular film sealed on both ends forming the shell 3 as shown in Figure 1. The film can be manufactured from cost effective and environmentally sustainable, flexible LDPE material, or similar. Figures 2 and 3 the cartridge packaging 1 is illustrated with a three-cartridge configuration. However, other sizes are conceivable within the scope of this invention. The examples are shown with polymer-based cartridges 2, but it is envisaged that the disclosure could be applied instead to glass cartridges.

[0062] In the example of Figures 2 and 2A, the cartridge packaging 1 is constructed using a simple flow wrapped film as a shell 3 around each cartridge 2, to form linear pack of three cartridges 2, which could be supplied without any further packaging. As mentioned above, the film can be a flexible LDPE material. The joints between the wrapped cartridges 2 include a heat seal 4 with a perforation in the middle which forms a weakened line 5. Individual cartridges 2 may be separated by cutting, or tearing through the perforated weakened line 5, leaving a seal 4 on both the removed pack and the pack from which it was separated.

[0063] The individual flow wrapped cartridges 2 can then be opened through initiation features, e.g. a notch 6 (see Figure 3A), which create a localised stress concentration in the material, enabling an easier tearing action.

[0064] Instructions could be provided to users in a paper format alongside the flow-wrapped pack, or could be accessed electronically via a QR Code printed on to the flow wrapped material of the shell 3.

[0065] This second example has a very low quantity of packaging material by mass, and might be supplied in cardboard secondary packaging boxes to the health care setting, then provided to end users either with no packaging, or in a standard pharmacy paper bag, e.g. as described in more detail below with respect to Figures 9 and 10.

[0066] 16. Dezember 2025 S 100 P 559 WO Figures 3 and 3A show a third example of a flow wrapped cartridge packaging 1 which shares attributes with the first and second example. It uses a simple flow wrapped shell 3 construction to create individually sealed cartridge packs. The individual packs may be separated by tearing a perforation feature, here a weakened lines 5 running parallel to the main axes of the cartridges 2. It is a solution not requiring additional packaging components, like cardboard supports. Instructions can be provided separately as paper or digitally via a printed code.

[0067] As an optional feature, a standard hanger with an elongate opening is provided that may be used in the health care setting to store and / or display the cartridges 2 in a refrigerator. In this third example, the cartridge packs are stored in a side-by-side arrangement rather than top-to-bottom as in the second example, which provides a potentially more convenient and robust pack size for user transport and storage.

[0068] Figures 4 to 6 depict a fourth example of a flow wrapped cartridge packaging 1 which uses a simple flow wrapped construction to create individually sealed cartridge packs. The main difference of this fourth example is the addition a cardboard housing as a secondary packaging box 8. The secondary packaging box 8 is constructed using pre-printed and pre-cut carboard that is folded and glued. A user is able tear open the secondary packaging box 8 to access the flow wrapped cartridge packs.

[0069] The housing or secondary packaging box 8 has several functions: It allows individual cartridge packs as in the first example to be contained, i.e. they do not need to be attached to each another as in the second or third example. It may be open at the front and sides to permit visibility of the items. It provides a more regular outer shape, allowing the packs to be handled and stored, e.g. in further packaging, in a more efficient fashion. It provides a greater degree of protection for the flow wrapped cartridge packs. A patient instruction leaflet 9 can be stored between the cartridge packs and the secondary packaging box 8. It provides additional surface area for brand and / or produce information. It may also be used to provide a printed QR code for electronic patient instructions.

[0070] 16. Dezember 2025 S 100 P 559 WO In the example of Figures 4 to 6, the secondary packaging box 8 substantially comprises at least a top wall 10, a bottom wall 11 , a front wall 12 and a back wall 13. The secondary packaging box 8 may be made from a single piece blank. In the depicted example, the top wall 10 comprises at least one withdrawal cut-out and webs of the top wall 10 are partially folded onto the bottom wall 11 .

[0071] A similar fifth example is depicted in Figures 7 and 8. This example shares attributes with the fourth example, including individual cartridge packs contained within a cardboard housing or secondary packaging box 8. The secondary packaging box 8 in this example provides a range of further functions, including a tamper feature in the form of a tear-off strip 14 that must be removed to open the pack, and provides tamper evidence prior to use. The tear-off strip is delimited by two weakened lines 15, e.g. perforated lines. A cover 16 may be provided that conceals the cartridges 2 and folds open to access the cartridges. Retainer openings 17 in a wall segment may contain the individual flow wrapped cartridges, but allow improved used access to help remove them, and help prevent them from accidentally falling out.

[0072] Patient instructions could be provided on a paper sheet, or be printed onto the inner face of the cover 16, or could be accessed electronically via a QR code printed on the shell 3 and / or in the secondary packaging box 8.

[0073] The sixth example depicted in Figures 9 and 10 provides a system for more sustainable distribution of cartridges 2. It comprises: a pharmacy pack as secondary packaging box 8, several cartridge packs, e.g. as shown in Figures 1 to 3, optionally user packs 18 and / or instruction leaflets 9. For example, the pharmacy pack is a box provided to pharmacies that contains a large quantity of cartridge packs, user packs 18 and instruction leaflets 9. Cartridge packs are cartridges 2 individually flow wrapped in shell 3. A cartridge pack may be either a single flow wrapped cartridge as in Figure 1 or may be a set of several, e.g. three, cartridges 2 with shells 3 hinged together as in Figures 2 or 3. User packs 18 may be flat packed containers for a dispensing quantity of cartridge packs, e.g. three or five.

[0074] 16. Dezember 2025 S 100 P 559 WO This example provides a highly efficient and flexible distribution system, enabling pharmacists to dispense an individual (i.e. variable) number of cartridge packs, as required by each patients’ individual prescription. The user packs 18 are supplied in a flat condition to minimise the storage volume. They are then erected by the pharmacist when required as indicated in Figure 10.

[0075] The pharmacy pack may include internal separators 19 that divide the cartridge packs, user packs and patient instructions within the secondary packaging box 8. The separators 19 help with the management of items during packing, transit, and during the use at the pharmacy, particularly when partially full. Alternatively, instead of internal dividers 19, the pharmacy pack could contain smaller sub-packs of cartridges, user packs and instruction leaflets, to help manage storage in the health care setting.

[0076] The embodiment reduces the volume of packaging sent through a supply chain, through the efficient storage of cartridge packs, and the flat packing of the user packs 18 and instruction leaflets 9. It reduces the number of stock keeping units (SKUs) that need to be produced, stored and distributed. This concept improves manufacturing, storage and transportation efficiency and increased packing density in cold-chain, reducing energy use and carbon generation.

[0077] Alternatively, the physical patient instruction leaflets 9 could be replaced by a printed QR code on each user pack 18 or on each shell 3 of the flow wrapped cartridge packs, enabling electronic access to instructions.

[0078] 16. Dezember 2025 S 100 P 559 WO Reference Numerals

[0079] 1 cartridge packaging

[0080] 2 cartridge

[0081] 3 shell

[0082] 5 weakened line

[0083] 6 notch

[0084] 7 hanger

[0085] 8 secondary packaging box

[0086] 9 instruction leaflet

[0087] 10 top wall

[0088] 11 bottom wall

[0089] 12 front wall

[0090] 13 back wall

[0091] 14 tear-off strip

[0092] 15 weakened line

[0093] 16 cover

[0094] 17 retainer opening

[0095] 18 user pack

[0096] 19 separator

[0097] 16. Dezember 2025 S 100 P 559 WO

Claims

Claims1. A cartridge packaging with an outer shell (3) closed in a tamper proof manner and comprising at least one cartridge (2) filled with a liquid drug for use in a pen type drug delivery device, characterized in that the shell (3) is a flow wrapped film made of a flexible low-density polyethylene (LDPE) material tube which is heat sealed at two opposite ends.

2. The cartridge packaging according to claim 1 , wherein the shell (3) comprises at least one initiation notch (6).

3. The cartridge packaging according to claim 1 or 2 comprising at least two cartridges (2) which are each individually encased in a compartment of the flow wrapped film shell (3), wherein adjacent compartments are hinged to each other by one or more weakened lines (5).

4. The cartridge packaging according to claim 3, wherein the cartridges (2) are arranged substantially coaxially as a linear pack with the weakened lines (5) extending substantially perpendicular to the longitudinal axes of the cartridges (2).

5. The cartridge packaging according to claim 3, wherein the cartridges (2) are arranged substantially parallel to each other as a side by side pack with the weakened lines (5) extending substantially parallel to the longitudinal axes of the cartridges (2).

6. The cartridge packaging according to any one of the preceding claims further comprising a secondary packaging box (8) made of a cardboard material, wherein the shell (3) is at least partially encased by the secondary packaging box (8).

7. The cartridge packaging according to claim 6, wherein the secondary packaging box (8) is made from a single piece blank comprising at least a top wall (10), a bottom wall (11), a front wall (12) and a back wall (13).

16. Dezember 2025 S 100 P 559 WO8. The cartridge packaging according to claim 7, wherein the top wall (10) or the front wall (12) comprises at least one withdrawal cut-out and / or wherein the top wall (10) is partially folded onto the bottom wall (11).

9. The cartridge packaging according to claim 7, wherein the secondary packaging box (8) further comprises a closing flap or cover (16) and at least one tear-off strip (14) hinged to at least the closing flap or cover (16) by one or more weakened lines (15).

10. The cartridge packaging according to claim 7, wherein the secondary packaging box (8) further comprises two opposite side walls and at least one separator (19) wherein the separator (19) divides the interior space of the secondary packaging box (8) in a cartridge storing space and a user pack space.

11. The cartridge packaging according to claim 10, wherein the cartridge storing space comprises several sets each comprising at least two cartridges (2) which are each individually encased in a compartment of the flow wrapped film shell (3), wherein adjacent compartments are hinged to each other by one or more weakened lines (5).

12. The cartridge packaging according to claim 10 or 11 , wherein the user pack space comprises several pre-built user packs (18) in a flat folded condition from which the user packs (18) may be erected into a use condition.

13. The cartridge packaging according to any one of the preceding claims further comprising at least one instruction leaflet (9) and / or a code configured to permit access to user instructions.

14. The cartridge packaging according to any one of the preceding claims, wherein the at least one cartridge (2) is made from a polymer-based material or glass.

16. Dezember 2025 S 100 P 559 WO

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